オオモリ　テツペイ   Oomori Tetsupei   大森　鉄平    所属   医学部 医学科（東京女子医科大学病院）    職種   非常勤講師
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	Real-world safety and efficacy of twice-daily budesonide 2-mg foam in patients with ulcerative colitis: interim analysis of post-marketing surveillance.
掲載誌名	正式名：Expert opinion on pharmacotherapy 略　 称：Expert Opin Pharmacother ISSNコード：17447666/14656566
掲載区分	国外
巻・号・頁	22(11),pp.1505-1511
著者・共著者	Omori Teppei, Saruta Masayuki, Nagaki Akira, Arai Yuki, Ohta Akira, Kuramoto Kiyotoshi, Suzuki Yasuo
担当区分	筆頭著者
発行年月	2021/08
概要	Background: Budesonide foam 2 mg twice daily induced complete mucosal healing in patients with mild-to-moderate ulcerative colitis (UC) in a phase 3 study. Post-marketing surveillance is underway to assess the real-world outcomes in UC patients.Research design and methods: The authors performed an interim analysis of post-marketing surveillance in 182 patients with mild-to-moderate UC who received 2 mg budesonide foam rectally.Results: Budesonide foam was prescribed twice daily to 76.4% of patients for 7.6 ± 3.8 weeks (mean ± standard deviation). Seven patients (3.8%) had at least one adverse drug reaction (ADR). A serious ADR of enteritis infectious and glucocorticoid-related ADRs of acne and hypertrichosis were observed in one patient (0.5%) each. The partial Mayo scores significantly decreased from baseline to week 2 in patients with proctitis, left-sided colitis, and pancolitis (p < 0.01 versus baseline each). Clinical response and remission at week 6 were 75.9% (60/79) and 68.4% (54/79), respectively. At week 6, 72.6% (77/106) of the patients reported as 'good compliance' and 54.7% (58/106) of the patients as 'very easy' for administration, using a self-administered questionnaire.Conclusions: Budesonide foam appeared to be safe, efficacious, and well-accepted in a real-world cohort of patients with UC. Trial registration: JapicCTI-183858.
DOI	10.1080/14656566.2021.1905796
PMID	33832402